Keverprazan plus amoxicillin versus rabeprazole-based therapy for first-line H. pylori treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized controlled Phase 4 study will enroll 414 adults with confirmed H. pylori infection and randomize them 1:1:1 to Keverprazan dual therapy for 10 days, Keverprazan dual therapy for 14 days, or rabeprazole quadruple therapy for 14 days. The protocol includes a screening visit and three on-treatment visits (one may be by phone) to record vitals, concomitant medications, adverse events, and adherence. The project duration is approximately one year from ethics approval and clinical registration, with eradication and safety compared across groups. Eligible participants are adults 18–65 who are treatment-naïve for H. pylori and meet the study’s washout and health criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Adult patients aged 18 to 65 years old, regardless of gender;
2. H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H\&E staining or bacterial culture;
3. No previous history of H. pylori eradication therapy;
4. Subjects able to independently complete the recording of the subject diary card;
5. Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form.

Exclusion Criteria

1. Use of acid-suppressing drugs such as proton pump inhibitors (PPIs), potassium-competitive acid blocker (P-CAB), H2 receptor antagonists, etc., within 2 weeks before enrollment, or use of antibiotics within 4 weeks before enrollment;
2. Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.;
3. Previous history of esophageal or gastric surgery;
4. Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases;
5. Participants with allergies or hypersensitivity to keverprazan, rabeprazole, amoxicillin, clarithromycin, bismuth agents, including its excipients (such as mannitol, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, etc.);
6. Female participants who are pregnant, breastfeeding;
7. Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events;
8. Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators;
9. Deemed unsuitable for participation in the study by the investigator for any other reason.

Where it's running

• The Second Affiliated Hospital Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Qin Du — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Jun Ye
• Email: wzmcyejun@zju.edu.cn
• Phone: 13858168852

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.